Urinary Retention After Total Laparoscopic Hysterectomy With Immediate Foley Catheter Removal Versus Backfill Void Trial
Completed · Not applicable
Conditions studied: Urinary Retention, Voiding Disorders
In brief
Acute urinary retention is a complication of hysterectomies that can result in bladder over-distension and long term bladder dysfunction. The incidence of acute urinary retention after total laparoscopic hysterectomy (TLH) has been reported to be anywhere between 4% and 34%. Studies have varied in the method of post-operative bladder challenge and the modality of hysterectomy included. Moreover, most of the published studies are retrospective chart reviews or prospective observational studies, with a lack of randomized controlled trials. Risk factors for urinary retention include type of anesthesia used, how the hysterectomy is performed, use of post-operative narcotics, pre-operative urinary retention, and possibly aggressive bladder dissection. With the increased trend towards same-day discharge following TLH, urinary retention may cause unnecessary patient distress and a worsened post-operative course. Standardization of post-hysterectomy bladder challenge and identification of risk factors for urinary retention may aid in preventing urinary retention or acute bladder dysfunction. The primary objective is to compare the rate of void trial failure after TLH with the backfill technique versus the autofill technique.
Key facts
- Study ID
- NCT03141372
- Run by
- Sara Farag
- People needed
- 84
- Starts
- 2017-05-16
- Expected to finish
- 2018-04-30
- Last updated by the study team
- 2018-10-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Females at least 18 years of age
- Understand and voluntarily sign an informed consent form
- English-speaking (able to read and understand English)
- Undergoing total laparoscopic hysterectomy for benign indication
You may not qualify if…
- Undergoing concomitant procedures in addition to hysterectomy which may cause urinary dysfunction
- Undergoing robotic-assisted laparoscopy or laparotomy
- Known history of pre-operative urinary incontinence or retention
- History of prior bladder or prolapse surgery
- Neurologic or spinal cord injury affecting bladder function
- Pregnant women
- Evidence of gynecologic malignancy
- Currently taking anticholinergic medications
Where it is running
- Cleveland Clinic Florida — Weston, Florida, United States
Full record on ClinicalTrials.gov
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